Using the S100B Protein for Emergency Headache Management Care (S100) (S100)

• ClinicalTrials.gov Identifier: NCT03490500
• Recruitment Status: Completed
• First Posted: April 6, 2018
• Last Update Posted: February 1, 2022
• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Information provided by (Responsible Party): Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Study Description

Brief Summary:

The purpose of this study is to determine the negative predictive value of protein S100B that could exclude subarachnoid and intracranial haemorrhage for patient that present severe headache within the last 3 hours.

Condition or disease
Headache, Migraine; Hemorrhage

Detailed Description:

This study will be proposed to every patient that correspond to eligibility criteria, such as presenting a severe headache (Visual Analog Scale ≥ 6/10) within 3 hours before arriving to the emergency.

After signing the informed consent, a blood sample will be taken in order to dosage S100B protein of each patient, and then they will have a brain scan.

The trial ends after the brain scan for each patient. Results of brain scans will be compared with results of S100B dosage.

Study Design

• Study Type: Observational
• Actual Enrollment: 63 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Improving the Headache Management Care in the Emergency Unit by Using a Biological Marker: S100B Protein.
• Actual Study Start Date: October 24, 2018
• Actual Primary Completion Date: January 24, 2020
• Actual Study Completion Date: January 24, 2020

Groups and Cohorts

Group/Cohort
S100B protein dosage; Biological

Outcome Measures

Primary Outcome Measures :

1. Evaluate the interest of PS100B dosage in the severe headache therapeutic management [ Time Frame: 15 months ]
   Negative predictive value of PS100B dosage below the reference value of 0.10 µG/L for intracerebral haemorrhage lesion

Secondary Outcome Measures :

1. Frequency of Intracranial Bleeding in patient with severe headache [ Time Frame: 15 months ]
   Incidence of intracranial bleeding in patient with severe headache
2. Frequency of subarachnoid hemorrhage in patient with severe headache [ Time Frame: 15 months ]
   Incidence of subarachnoid haemorrhage in patient with severe headache
3. Frequency of intracranial haemorrhage in migraine patient with severe headache at inclusion [ Time Frame: 15 months ]
   Incidence of intracranial haemorrhage in migraine patient with severe headache at inclusion
4. Evaluate the number of lumbar puncture that could have been avoided [ Time Frame: 15 months ]
   The ratio of patient with a normal scan and a PS100 dosage < 0.10µg/L, on patient eligible for lumbar puncture according to the usual practice
5. Evaluate the number of cerebral scan that could have been avoided [ Time Frame: 15 months ]
   The ratio of patient with a normal scan and a PS100 dosage < 0.10 µg/L, on patient eligible for cerebral scan according to the usual practice
6. Evaluate the number of lumbar puncture's complications that could have been avoided. [ Time Frame: 15 months ]
   The ratio of patients with PS100 < 0.10µg/L and normal cerebral scan on the total number of patients included

Biospecimen Retention:   Samples Without DNA

blood sample for protein S100B dosage

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

The population will be recruited in the emergency unit

Criteria

Inclusion Criteria:

• Male or female over 18 years-old
• Patient presenting at the Emergency Service a non-traumatic severe headache lasting for less than 3 hours. The severity is defined as a VAS ≥ 6/10
• Blood sample can be taken within 1 hour following the emergency admission
• VAS > 6 or Glasgow < 8
• Signed and dated informed consent by patient, or trusted person, or family

Exclusion Criteria:

• Patient presenting headache after head trauma
• Pregnant or breastfeeding women
• Patient with a pathology causing the elevation of PS100B's rate such as Alzheimer's disease, Creuzfeld-Jacob's disease, Multiple Sclerosis, cerebral tumour, trisomy 21, melanoma (diabetes excluded)
• Patient covered by social security regimen or equivalent
• Patient under guardianship (legal protection)
• Patient deprived of liberty by court or administrative order
• Any condition that could influence PS100B's dosage results according to the physician.

Contacts and Locations

Locations

France

Hôpital d'Instruction des Armées Laveran

Marseille, Bouches-du-Rhône, France, 13000

Hôpital d'Instruction des Armées Sainte Anne

Toulon, Var, France, 83000

Centre Hospitalier Intercommunal de Toulon La Seyne-sur-Mer

Toulon, Var, France, 83056

Sponsors and Collaborators

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

• Study Director: Aurélien Renard, MD; Hôpital d'instruction des armées Sainte-Anne

More Information

Publications:

Latinovic R, Gulliford M, Ridsdale L. Headache and migraine in primary care: consultation, prescription, and referral rates in a large population. J Neurol Neurosurg Psychiatry. 2006 Mar;77(3):385-7.

Edlow JA, Panagos PD, Godwin SA, Thomas TL, Decker WW; American College of Emergency Physicians. Clinical policy: critical issues in the evaluation and management of adult patients presenting to the emergency department with acute headache. Ann Emerg Med. 2008 Oct;52(4):407-36. doi: 10.1016/j.annemergmed.2008.07.001.

Biberthaler P, Linsenmeier U, Pfeifer KJ, Kroetz M, Mussack T, Kanz KG, Hoecherl EF, Jonas F, Marzi I, Leucht P, Jochum M, Mutschler W. Serum S-100B concentration provides additional information fot the indication of computed tomography in patients after minor head injury: a prospective multicenter study. Shock. 2006 May;25(5):446-53.

Gilbert JW, Johnson KM, Larkin GL, Moore CL. Atraumatic headache in US emergency departments: recent trends in CT/MRI utilisation and factors associated with severe intracranial pathology. Emerg Med J. 2012 Jul;29(7):576-81. doi: 10.1136/emermed-2011-200088. Epub 2011 Aug 19.

Morgenstern LB, Huber JC, Luna-Gonzales H, Saldin KR, Grotta JC, Shaw SG, Knudson L, Frankowski RF. Headache in the emergency department. Headache. 2001 Jun;41(6):537-41.

Edlow JA, Caplan LR. Avoiding pitfalls in the diagnosis of subarachnoid hemorrhage. N Engl J Med. 2000 Jan 6;342(1):29-36. Review.

• Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• ClinicalTrials.gov Identifier: NCT03490500
• Other Study ID Numbers: 2017-CHITS-07; 2018-A00070-55 ( Other Identifier: Id-RCB )
• First Posted: April 6, 2018
• Last Update Posted: February 1, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is no IPD sharing plan

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer:

protein S100B; negative predictive value; headache; intracranial hemorrhage

Additional relevant MeSH terms:

Migraine Disorders; Emergencies; Hemorrhage; Headache; Disease Attributes; Pathologic Processes; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases